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１２ 名健康志愿者交叉口服单剂量国产辛伐他汀片和舒降之片剂 ４０ ｍ ｇ，应用 Ｈ Ｐ Ｌ Ｃ 法测定其经时血药浓度。实验数据经 ３ Ｐ９７ 程序处理，两制剂口服吸收呈二室模型。辛伐他汀片和舒降之各相关药代动力学参数： Ｃｍ ａｘ 为（１０５．９７±２５．９８） μｇ／ Ｌ 和（１１０．３２±２７．６７） μｇ／ Ｌ， Ｔｍ ａｘ 为（１．９０±０３７） ｈ和（１．９９±０．３５） ｈ， Ａ Ｕ Ｃ 为（９７０．０６±１１７．７４）（μｇ／ Ｌ·ｈ ）和（９７６．８１±１５０．１３）（μｇ／ Ｌ·ｈ ），根据辛伐他汀片和舒降之的代谢产物辛伐他汀酸（ Ｓ Ｖ Ａ）血药浓度时间曲线下面积 Ａ Ｕ Ｃ，计算辛伐他汀片相对生物利用度为（９８．６２±１２．０１）％ 。经方差分析及双单侧 Ｔ 检验和（１－ ２α）置信区间分析，显示两制剂 Ａ Ｕ Ｃ值在制剂间、周期间和个体间均无显著性差异，提示辛伐他汀片和舒降之片具有生物等效性。
Twelve healthy volunteers were given a single oral dose of 40 mg simvastatin tablets and Shu Zu tablets. The plasma concentrations of Hs-CRP were measured by H plc method. The experimental data was processed by 3 P97 program, and the two preparations were taken orally in a two-compartment model. The relevant pharmacokinetic parameters of Simvastatin tablets and Shuqin were: Cm ax was (105.97 ± 25.98) μg / L and (110.32 ± 27.67) μg / L respectively, Tm ax was .90 ± 0.37) h and (1.99 ± 0.35) h, respectively. AUC was (970.06 ± 117.74) μg / L · h and (976.81 ± 150.13) (Μg / L · h). The relative bioavailability of simvastatin tablets was calculated according to the area under the simvastatin and simvastatin (S V A) plasma concentration time curves (AUC) (98.62 ± 12.01)%. Analysis of variance and double unilateral T-test and (1- 2α) confidence interval analysis showed that there was no significant difference in A U C between preparations, weeks and individuals, suggesting that simvastatin tablets and sulpiride tablets The tablets are bioequivalent.